Senior Biostatistician or Principal Biostatistician

This position is responsible for leading the biostatistics component of projects across multiple studies or programs. A Principal Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. Provides external statistical consultancy for sponsor companies and serves as a departmental resource for complex statistical questions, study design considerations, and protocol development.

**JOB RESPONSIBILITIES**:
Work as the assigned statistician on multiple studies or program studies, independently or as the lead statistician as required.

Coordinate the activities of other biostatistics/programming personnel on assigned projects to ensure timely completion of high-quality work. Provides independent review of project work produced by other biostatisticians/statistical programmers in the department.

Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.

Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.

May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.

Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.

Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high-quality database and the planned analysis.

Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.

May lead complex or multiple projects and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.

Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.

Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.

Provides statistical programming support as needed.

May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs.

Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs, ensuring inspection readiness.

Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.

Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others

Performs other work-related duties as assigned.

Minimal travel may be required.

**REQUIRED PROFILE**:
Graduate degree in biostatistics, maths or related discipline.

Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.

Proficiency in SAS programming and any other language.

Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.

Experience with regulatory submissions preferred.

Excellent written and verbal communication skills.

Ability to read, write, speak, and understand English.